FDA Label NDC 50126-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Natural Solutions for the product (NDC 50126-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, warnings and precautions, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Purpose:

Pediculicide

Other Information:

Store at 60-85 Degrees F (15-30 degrees C)

Manufactured for Advanced Natural Solutions, Inc.

4187 Artesa Dr. Boynton Beach FL 33436

For adverse event reporting, call 800-294-6816

Warnings And Precautions

Warnings (for external use only):

  • Keep out of reach of children
  • Avoid getting into eyes to prevent irritation.  If there is accidental eye contact, flush eyes thoroughly with cool water.
  • In case of accidental ingestion, seek professional medical assistance or contact a Poison Control Center Immediately
    • Ask a doctor before use if you have:
    • Infestation of eyebrows or eyelashes
    • Children under 6 months of age
      • Stop use and ask doctor if:
      • Skin irritation or infection is present or develops

Inactive Ingredient

Cocos Nuceferas (coconut oil), Extracts of Wrightia Tinctoria and Scorus Calamus, Amla Extract, Shikekai Extracts, Protease Enzymes, Lavendar Oil, Water.

Indications & Usage

Directions:  Adult and children 6 months of age or older:

  • Shake well
  • Apply liberally to wet hair and entire scalp, starting at the nape of the neck and behind ears working forward
  • Massage in thoroughly until entire head is covered; to be effective, all lice and nits must come in full contact with the product
  • Leave in hair for 15 minutes
  • Use comb to remove all lice and eggs
  • Rinse hair thoroughly with warm water
  • Repeat as necessary
    • Uses:  Homeopathic remedy for treatment of head lice as per Materia Medica.

Package Label.Principal Display Panel

Repels Lice and Nits from Coming Back!

Clearlice Conditioner

Homeopathic Pediculicide

Makes hair soft and slick so lice and nits don't stick!

ClearliceFront.jpg

Front Label (Clearlicefront)

Front Label (Clearlicefront)


ClearliceBack.jpg

Back Label (Clearliceback)

Back Label (Clearliceback)

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